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Enrolling by invitation NCT06431191

Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture

No phase Interventional Full Rotator Cuff Tear Microfracture Procedure Double Raw Repair Lateral Raw Repair

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lateral raw, double raw.
Who it may be relevant to
Registry conditions: Full Rotator Cuff Tear, Microfracture Procedure, Double Raw Repair, Lateral Raw Repair. Basic parameters: 20 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Does Medial Raw Anchor Necessary During Tendon Repair Combined With Microfracture in Small to Medium Size Rotator Cuff Tear

Overview

This study is a prospective randomized controlled study of rotator cuff repair with lateral raw or double raw combined with microfracture procedure. The patients with rotator cuff tear were randomly divided into groups before the operation. The patients were followed up before and, 3 months, 6 months, 12 months and 24 months after surgery. In different time periods, the quantitative and qualitative indicators including pain, functional score, muscle strength, MRI performance, etc. were compared between groups at the same time period to evaluate the difference in the effect of double raw or only lateral raw repair combined with microfracture on the treatment of rotator cuff. In order to figure out whether medial raw anchor necessary during tendon repair combined with microfracture in small to medium size rotator cuff tear.

Interventions

  • Procedure lateral raw
    lateral raw repair for full tear rotator cuff combined microfracture procedure, without medial raw
  • Procedure double raw
    double raw repair for full tear rotator cuff combined microfracture procedure

Primary outcome measures

  • rotator cuff re-tear rate [Time frame: 6, 12, 24 months postoperatively]
Secondary outcome measures (8)
  • VAS (Visual Analogue Scale) [Time frame: 1,2,3,7 days postoperatively and 3,6,12,24 months postoperatively]
  • ASES(American Shoulder and Elbow Surgeons'Form) [Time frame: 3,6,12,24 months postoperatively]
  • Constant score [Time frame: 3,6,12,24 months postoperatively]
  • UCLA (University LosAngeles scoring system) [Time frame: 3,6,12,24 months postoperatively]
  • SST (simple shoulder test) [Time frame: 3,6,12,24 months postoperatively]
  • front extension, external rotation and internal rotation strength of shoulder [Time frame: 6,12,24 months postoperatively]
  • surgical time [Time frame: immediately after the surgery]
  • Hospitalization expenses [Time frame: immediately after the patient discharge]

Eligibility criteria

Inclusion criteria

  • Arthroscopy confirmed small to medium full rotator cuff tear
  • Unilateral rotator cuff injury
  • Voluntarily accept randomized controlled grouping, cooperate with treatment and follow up patients
  • Young and middle-aged patients aged 20 to 60

Exclusion criteria

  • Previous shoulder surgery (incision or arthroscopy)
  • Combined with diseases of other parts of the same limb
  • Combined with Bankart injury, acromioclavicular joint disease, greater tuberosity fracture, glenoid fracture and so on
  • Bilateral onset
  • Unable or unwilling to receive clinical follow-up

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Jishuitan hospital — Beijing

Identifiers

NCT: NCT06431191 · luyi

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗